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Drug overview for FLOLAN (epoprostenol sodium (glycine)):
Generic name: EPOPROSTENOL SODIUM (GLYCINE) (E-poe-PROST-en-ol)
Drug class: Pulmonary Antihypertensive Agents - Prostacyclin-type
Therapeutic class: Cardiovascular Therapy Agents
Epoprostenol (PGI2, PGX, prostacyclin), a naturally occurring prostaglandin, is a short-acting vasodilator and platelet-aggregation inhibitor.
No enhanced Uses information available for this drug.
Generic name: EPOPROSTENOL SODIUM (GLYCINE) (E-poe-PROST-en-ol)
Drug class: Pulmonary Antihypertensive Agents - Prostacyclin-type
Therapeutic class: Cardiovascular Therapy Agents
Epoprostenol (PGI2, PGX, prostacyclin), a naturally occurring prostaglandin, is a short-acting vasodilator and platelet-aggregation inhibitor.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for FLOLAN (epoprostenol sodium (glycine)) have been approved by the FDA:
Indications:
Pulmonary arterial hypertension
Professional Synonyms:
Hypertensive pulmonary arterial disease
Pulmonary hypertensive arterial disease
Indications:
Pulmonary arterial hypertension
Professional Synonyms:
Hypertensive pulmonary arterial disease
Pulmonary hypertensive arterial disease
The following dosing information is available for FLOLAN (epoprostenol sodium (glycine)):
Dosage of epoprostenol sodium is expressed in terms of epoprostenol. There is considerable interindividual variability in patient response to epoprostenol and dosage must be individualized. Dosage should be carefully titrated until therapeutic effect is achieved or adverse effects become intolerable.
Epoprostenol sodium is administered by continuous IV infusion via a central venous catheter with a portable controlled-infusion device. A peripheral IV catheter may be used temporarily to administer the infusion until central venous access is established. Consult the manufacturer's labeling for ambulatory infusion-device specifications.
Delivery system malfunctions (e.g., infusion-device failure, occluded catheter) may result in inadvertent overdosage or underdosage. To avoid potential interruptions in drug delivery secondary to equipment malfunction, patients should have access to a back-up IV infusion device and infusion sets. A multi-lumen catheter should be considered for patients who routinely receive other IV drugs.
Epoprostenol also has been administered by oral inhalation (via nebulization+ through the ventilator circuit) in patients with acute respiratory distress syndrome (ARDS)+ receiving mechanical ventilation. Store unopened vials of Flolan(R) powder for injection at room temperature (15-25degreesC), in the carton, and protect from light. Store unopened vials of the sterile diluent for Flolan(R) at room temperature (15-25degreesC).
Do not freeze the diluent. Store vials of Veletri(R) at controlled room temperature (20-25degreesC); store in the carton and do not expose to direct sunlight.
Delivery system malfunctions (e.g., infusion-device failure, occluded catheter) may result in inadvertent overdosage or underdosage. To avoid potential interruptions in drug delivery secondary to equipment malfunction, patients should have access to a back-up IV infusion device and infusion sets. A multi-lumen catheter should be considered for patients who routinely receive other IV drugs.
Epoprostenol also has been administered by oral inhalation (via nebulization+ through the ventilator circuit) in patients with acute respiratory distress syndrome (ARDS)+ receiving mechanical ventilation. Store unopened vials of Flolan(R) powder for injection at room temperature (15-25degreesC), in the carton, and protect from light. Store unopened vials of the sterile diluent for Flolan(R) at room temperature (15-25degreesC).
Do not freeze the diluent. Store vials of Veletri(R) at controlled room temperature (20-25degreesC); store in the carton and do not expose to direct sunlight.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for FLOLAN (epoprostenol sodium (glycine)):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Sodium Iodide I 131/Myelosuppressives; Immunomodulators SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Sodium iodide I 131 can cause depression of the hematopoetic system. Myelosuppressives and immunomodulators also suppress the immune system.(1) CLINICAL EFFECTS: Concurrent use of sodium iodide I 131 with agents that cause bone marrow depression, including myelosuppressives or immunomodulators, may result in an enhanced risk of hematologic disorders, including anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia. Bone marrow depression may increase the risk of serious infections and bleeding.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of sodium iodide I 131 states that concurrent use with bone marrow depressants may enhance the depression of the hematopoetic system caused by large doses of sodium iodide I 131.(1) Sodium iodide I 131 causes a dose-dependent bone marrow suppression, including neutropenia or thrombocytopenia, in the 3 to 5 weeks following administration. Patients may be at increased risk of infections or bleeding during this time. Monitor complete blood counts within one month of therapy. If results indicate leukopenia or thrombocytopenia, dosimetry should be used to determine a safe sodium iodide I 131 activity.(1) DISCUSSION: Hematologic disorders including death have been reported with sodium iodide I 131. The most common hematologic disorders reported include anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia.(1) |
HICON, SODIUM IODIDE I-131 |
There are 2 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Tizanidine/Selected Antihypertensives SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Tizanidine is an alpha-2 agonist. Concurrent use with antihypertensive agents may result in additive effects on blood pressure.(1) CLINICAL EFFECTS: Concurrent use of antihypertensives and tizanidine may result in hypotension.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Patients receiving concurrent therapy should be monitored for hypotension. The risk of hypotension may be decreased by careful titration of tizanidine dosages and monitoring for hypotension prior to dose advancement. Counsel patients about the risk of orthostatic hypotension.(1) DISCUSSION: Severe hypotension has been reported following the addition of tizanidine to existing lisinopril therapy.(2-4) |
TIZANIDINE HCL, ZANAFLEX |
| Apomorphine/Selected Antihypertensives and Vasodilators SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Apomorphine causes dose-dependent decreases in blood pressure. Concurrent use with antihypertensive agents may result in additive effects on blood pressure.(1) CLINICAL EFFECTS: Concurrent use of antihypertensives and apomorphine may result in orthostatic hypotension with or without dizziness, nausea, or syncope.(1) PREDISPOSING FACTORS: The risk of orthostatic hypotension may be increased during dose escalation of apomorphine and in patients with renal or hepatic impairment.(1) PATIENT MANAGEMENT: Patients receiving concurrent therapy should be monitored for hypotension. Counsel patients about the risk of orthostatic hypotension.(1) DISCUSSION: Healthy volunteers who took sublingual nitroglycerin (0.4 mg) concomitantly with apomorphine experienced a mean largest decrease in supine systolic blood pressure (SBP) of 9.7 mm Hg and in supine diastolic blood pressure (DBP) of 9.3 mm Hg, and a mean largest decrease in standing SBP and DBP of 14.3 mm Hg and 13.5 mm Hg, respectively. The maximum decrease in SBP and DBP was 65 mm Hg and 43 mm Hg, respectively. When apomorphine was taken alone, the mean largest decrease in supine SBP and DBP was 6.1 mm Hg and 7.3 mm Hg, respectively, and in standing SBP and DBP was 6.7 mm Hg and 8.4 mm Hg, respectively.(1) |
APOKYN, APOMORPHINE HCL, ONAPGO |
The following contraindication information is available for FLOLAN (epoprostenol sodium (glycine)):
Drug contraindication overview.
*Long-term use in patients with CHF due to severe left ventricular systolic dysfunction. *Long-term use in patients who develop pulmonary edema during initial dosage titration (Veletri(R) only). *Known hypersensitivity to epoprostenol or structurally related drugs.
*Long-term use in patients with CHF due to severe left ventricular systolic dysfunction. *Long-term use in patients who develop pulmonary edema during initial dosage titration (Veletri(R) only). *Known hypersensitivity to epoprostenol or structurally related drugs.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Severe chronic heart failure |
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Pulmonary edema |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Increased risk of bleeding |
The following adverse reaction information is available for FLOLAN (epoprostenol sodium (glycine)):
Adverse reaction overview.
The most common adverse reactions reported among patients treated with Flolan(R) include dizziness, jaw pain, headache, musculoskeletal pain, and nausea/vomiting. The most common adverse reactions reported among patients initiating treatment with Veletri(R) include nausea/vomiting, headache, hypotension, flushing, chest pain, anxiety, dizziness, bradycardia, dyspnea, abdominal pain, musculoskeletal pain, and tachycardia. The most common adverse reactions reported among patients receiving chronic dosing of Veletri(R) include headache, jaw pain, flushing, diarrhea, nausea/vomiting, flu-like symptoms, and anxiety/nervousness.
The most common adverse reactions reported among patients treated with Flolan(R) include dizziness, jaw pain, headache, musculoskeletal pain, and nausea/vomiting. The most common adverse reactions reported among patients initiating treatment with Veletri(R) include nausea/vomiting, headache, hypotension, flushing, chest pain, anxiety, dizziness, bradycardia, dyspnea, abdominal pain, musculoskeletal pain, and tachycardia. The most common adverse reactions reported among patients receiving chronic dosing of Veletri(R) include headache, jaw pain, flushing, diarrhea, nausea/vomiting, flu-like symptoms, and anxiety/nervousness.
There are 13 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Bacterial sepsis Hemorrhage Hypotension Skin ulcer Tachycardia |
Thrombocytopenic disorder |
| Rare/Very Rare |
|---|
|
Anemia Hepatic failure High output heart failure Pancytopenia Pulmonary thromboembolism Splenomegaly Worsening of chronic heart failure |
There are 26 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Agitation Chest pain Diarrhea Dizziness Eczema Flu-like symptoms Flushing Headache disorder Injection site infection Jaw pain Musculoskeletal pain Myalgia Nausea Nervousness Skin rash Symptoms of anxiety Urticaria Vomiting |
Acute abdominal pain Anorexia Bradycardia Hypoesthesia Paresthesia |
| Rare/Very Rare |
|---|
|
Ascites Hyperthyroidism Pulmonary edema |
The following precautions are available for FLOLAN (epoprostenol sodium (glycine)):
Safety and efficacy of epoprostenol have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
A drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes has not been demonstrated in limited data from case reports and case series describing epoprostenol use during pregnancy. Untreated pulmonary arterial hypertension (PAH) in pregnancy increases the risk for maternal heart failure, stroke, preterm delivery, and maternal and fetal death.
It is not known whether epoprostenol is distributed into milk. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for epoprostenol and any potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition.
Clinical studies of epoprostenol sodium did not include sufficient numbers of patients 65 years of age or older to determine whether geriatric patients respond differently than younger patients. Other reported clinical experience has not identified differences in responses between geriatric and younger patients. In general, titrate dosage carefully in geriatric patients. Consider the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly.
The following prioritized warning is available for FLOLAN (epoprostenol sodium (glycine)):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for FLOLAN (epoprostenol sodium (glycine))'s list of indications:
| Pulmonary arterial hypertension | |
| I27.0 | Primary pulmonary hypertension |
| I27.21 | Secondary pulmonary arterial hypertension |
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